Androgenetic AlopeciaNCT05129254
Thulium Laser and Topical Platelet Rich Plasma (PRP) vs. PRP Injection for the Treatment of Male Androgenetic Alopecia
A study testing Fractionated Thulium laser, Autologous Platelet Rich Plasma Injection and Autologous Platelet Rich Plasma Topical Application in people with Androgenetic Alopecia, run by Montefiore Medical Center.
Trial summary
The objective of this clinical study is to compare the safety and efficacy of a laser and topically applied platelet-rich plasma vs. platelet rich plasma injection in the treatment of male-pattern hair loss. Participating subjects will receive up to four (4) monthly treatments and will have a 12 month follow-up period. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Fractionated Thulium laser, Autologous Platelet Rich Plasma Injection and Autologous Platelet Rich Plasma Topical Application
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male, ≥ 18 years of age at time of informed consent, seeking treatment for hair loss.
- Subject must voluntarily sign and date an IRB approved informed consent form
- Subjects with diagnosis of androgenetic alopecia with hair loss recorded over the past 6 months. (Norwood Hamilton Class 3-4 for males)
- Able to read, understand and voluntarily provide written informed consent.
- Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regime during the study.
- Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Who cannot join
- Subjects does not have the capacity to consent to the study
- Subject has other types of alopecia of the scalp (i.g., alopecia areata, scarring alopecia)
- Use of minoxidil or 5-alpha reductase inhibitors (i.e., finasteride, dutasteride) 3 months prior to screening date.
- Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject.
- Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
- History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months.
Show all 11Show fewer
- History or current use of the following prescription medications:
- Immunosuppressive medications/biologics, 6 months prior to and during the study ii. Accutane or other systemic retinoids within the past twelve months
- Smoking or vaping in the past 12 months.
- History of hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders.
- History of major depressive disorders or endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism.
About this study
Official title: A Pilot Study Evaluating the Safety and Efficacy of a Fractionated Thulium Laser and Topical Platelet Rich Plasma vs. Platelet Rich Plasma Injection for the Treatment of Male Androgenetic Alopecia
The objective of this clinical study is to compare the safety and efficacy of a laser and topically applied platelet-rich plasma vs. platelet rich plasma injection in the treatment of male-pattern hair loss. Participating subjects will receive up to four (4) monthly treatments and will have a 12 month follow-up period.
Read the detailed description
This is a single institution, open-label, baseline-controlled, prospective study evaluating the use of a non-ablative fractionated thulium laser and topical autologous platelet-rich plasma (PRP) vs. PRP injection for the treatment of male androgenetic alopecia (MAA). Given that this is a feasibility study, the investigators do provide formal sample size calculations. The findings of the study will inform that effect size associated with the treatment under study, which will inform the sample size (and power) calculations of a full, large-scale study. For this feasibility study, the investigators conservatively estimated the number of eligible patients that can reasonably enroll in the study time frame. Over the course of 1 year, the investigators typically see 50 patients with this condition annually. Of those, the investigators anticipate 25-50% would be eligible and agree to participate in the study. Given this, the investigators reasonably believe the enrollment will be 12 male subjects, ≥ 18 years of age at time of signed informed consent, of whom 6 will be randomized to receive laser + topical PRP and 6 to receive PRP injection. Follow-up visits are planned for months 7, 10, 13, and 16. Standardized photography, hair density measurement of the treated scalp areas will be recorded Pre and Post Treatment at each visit. Measurement outcomes will be compared to baseline. During the initial visit, subjects who meet the study's eligibility criteria will receive the first treatment after signing informed consent form.
- Conditions
- Androgenetic Alopecia
- Being tested
- Fractionated Thulium laser, Autologous Platelet Rich Plasma Injection, Autologous Platelet Rich Plasma Topical Application
- Keywords
- alopecia, laser, platelet rich plasma, male pattern hair loss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated Thulium laserDevice
Also called LaseMD Lutronic Laser
For this study, the investigators will use non-ablative fractional Thulium laser (1927 nm), provided by LaseMD, (Lutronic, Inc, USA). The non-ablative fractionated treatments with minimal downtime provide synergistic benefit of minimizing tissue damage while improving treatment tolerance and efficiency. The laser works by creating micro-channels in the dermis of the pilosebaceous unit, while leaving bridges of untouched tissue for improved permeability, faster healing, and enhanced delivery of topical treatments. The parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by LaseMD. More than one affected area of the scalp may be treated per session. Each laser treatment will take approximately 10 to 15 minutes per subject. Pretreatment preparation will consist of cleaning the affected area of the scalp with antiseptic, either 70% ethanol or 3% hydrogen peroxide.
Autologous Platelet Rich Plasma InjectionProcedure or surgery
Platelet rich plasma (PRP) will be collected from participant in accordance with FDA section 21CFR640.34 regulation on collection and preparation of PRP. The collected blood will be processed according to manufacturer protocol to obtain PRP, which will be injected with a syringe and needle subcutaneously into the participant's scalp.
Autologous Platelet Rich Plasma Topical ApplicationProcedure or surgery
Platelet rich plasma (PRP) will be collected from participant in accordance with FDA section 21CFR640.34 regulation on collection and preparation of PRP. The collected blood will be processed according to manufacturer protocol to obtain PRP, which will be applied topically with a syringe to one or more affected areas on the participant's scalp that were previously treated with thulium laser.
| Study group | Role | What they receive |
|---|---|---|
| Thulium laser (1927nm) and post-treatment topically administered platelet rich plasma (PRP) | Experimental | All participating subjects will serve as their own baseline control and will receive treatment of their androgenetic alopecia with LaseMD, a 1927nm Fractionated Thulium laser and post-treatment topically applied autologous platelet rich plasma at monthly intervals for a total of 4 treatment. The total duration of laser application, venipuncture, PRP preparation, and topical administration will take approximately 30 minutes. Post-treatment surveillance: The subject will be observed in the clinic under direct supervision of the treating physician for any post-treatment side-effects for up to 15 minutes. Receives: Device: Fractionated Thulium laser; Procedure: Autologous Platelet Rich Plasma Topical Application |
| Platelet rich plasma injection | Experimental | All participating subjects will serve as their own baseline control and will receive treatment of their androgenetic alopecia with autologous platelet rich plasma injection at monthly intervals for a total of 4 treatment. The total duration of venipuncture, PRP preparation, and injection will take approximately 15 minutes. Post-treatment surveillance: The subject will be observed in the clinic under direct supervision of the treating physician for any post-treatment side-effects for up to 15 minutes. Receives: Procedure: Autologous Platelet Rich Plasma Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at month 7 follow-up.
Clinician Global Aesthetic Improvement Scale (CGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth.
Greatly decreased (-3) Moderately decreased (-2) Slightly decreased (-1) No change (0) Slightly increased (+1) Moderately increased (+2) Greatly increased (+3)
Based on a live assessment of the subject while referring to the subject's pre-treatment scalp photographs, the clinician will make an assessment of post-treatment hair growth.
Measured: 7 months
Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at month 7 follow-up.
Subject Global Aesthetic Improvement Scale (SGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth.
Greatly decreased (-3) Moderately decreased (-2) Slightly decreased (-1) No change (0) Slightly increased (+1) Moderately increased (+2) Greatly increased (+3) Subjects will be given a hand mirror for self-assessment of post-treatment hair growth compared to subject's pre-treatment scalp photographs.
Measured: 7 months
Secondary outcomes (2)
Percentage of subjects with score of 2 or 3 on Patient Satisfaction Questionnaire at month 7 follow-up.
Patient Satisfaction Questionnaire will use Lickert scale, ranging from "greatly decreased (-3)" to "greatly increased (+3)".
Greatly decreased (-3) Moderately decreased (-2) Slightly decreased (-1) No change (0) Slightly increased (+1) Moderately increased (+2) Greatly increased (+3)
The seven point Lickert scale will apply to following patient satisfaction questions:
Please choose the option that better represents the change in how your hair looks OVERALL in the area treated? Please choose the option that better represents the change in your hair THICKNESS in the area treated? Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated? Please choose the option that better represents the change in your hair DARKNESS in the area treated.
Measured: 7 months
Reported pain score on Numeric Rating Scale for Pain for first 4 months during treatment
The Numeric Rating Scale for Pain is an 11-point scale scored from 0-10, with 0 = no pain, 5 = moderate pain, and 10 = worst possible pain. Subjects select a value that is most in line with the intensity of their pain experienced during and after treatment with Thulium Laser and topical platelet rich plasma or platelet rich plasma injection. The NRS pain questionnaire will be given to participants to complete for each treatment for the first 4 months of the study.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Jul 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Study not initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To compare the efficacy of laser to improve delivery of topical platelet rich plasma (PRP) to promote hair growth, the investigators will employ a randomized, unblinded, baseline-controlled study design. There will be two parallel treatment arms in the study. The first arm will enroll six participants to receive thulium laser and topical PRP. The second arm will enroll six participants to receive PRP injection alone. Total participants enrolled will be twelve (12). There will be a total of 8 study visits (4 treatment and 4 follow-up) lasting 16 months. Each participant will receive an initial series of 4 treatments, either laser + topical PRP or PRP injection alone once a month for the first 4 months (month 1, 2, 3, 4). Thereafter, patients will be followed at 3-month intervals at month 7, 10, 13, and 16.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kseniya Kobets, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129254
- Sponsor's protocol ID
- 2021-13642
- Status last verified
- Aug 2022
- First submitted
- 10 Nov 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Safety and Efficacy of a Fractionated Thulium Laser and Topical Platelet Rich Plasma vs. Platelet Rich Plasma Injection for the Treatment of Male Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT05129254
- Acronym / sponsor ID
- 2021-13642
- Conditions
- Androgenetic Alopecia
- Keywords
- alopecia, laser, platelet rich plasma, male pattern hair loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to compare the safety and efficacy of a laser and topically applied platelet-rich plasma vs. platelet rich plasma injection in the treatment of male-pattern hair loss. Participating subjects will receive up to four (4) monthly treatments and will have a 12 month follow-up period.
Detailed description
This is a single institution, open-label, baseline-controlled, prospective study evaluating the use of a non-ablative fractionated thulium laser and topical autologous platelet-rich plasma (PRP) vs. PRP injection for the treatment of male androgenetic alopecia (MAA). Given that this is a feasibility study, the investigators do provide formal sample size calculations. The findings of the study will inform that effect size associated with the treatment under study, which will inform the sample size (and power) calculations of a full, large-scale study. For this feasibility study, the investigators conservatively estimated the number of eligible patients that can reasonably enroll in the study time frame. Over the course of 1 year, the investigators typically see 50 patients with this condition annually. Of those, the investigators anticipate 25-50% would be eligible and agree to participate in the study. Given this, the investigators reasonably believe the enrollment will be 12 male subjects, ≥ 18 years of age at time of signed informed consent, of whom 6 will be randomized to receive laser + topical PRP and 6 to receive PRP injection. Follow-up visits are planned for months 7, 10, 13, and 16. Standardized photography, hair density measurement of the treated scalp areas will be recorded Pre and Post Treatment at each visit. Measurement outcomes will be compared to baseline. During the initial visit, subjects who meet the study's eligibility criteria will receive the first treatment after signing informed consent form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To compare the efficacy of laser to improve delivery of topical platelet rich plasma (PRP) to promote hair growth, the investigators will employ a randomized, unblinded, baseline-controlled study design. There will be two parallel treatment arms in the study. The first arm will enroll six participants to receive thulium laser and topical PRP. The second arm will enroll six participants to receive PRP injection alone. Total participants enrolled will be twelve (12). There will be a total of 8 study visits (4 treatment and 4 follow-up) lasting 16 months. Each participant will receive an initial series of 4 treatments, either laser + topical PRP or PRP injection alone once a month for the first 4 months (month 1, 2, 3, 4). Thereafter, patients will be followed at 3-month intervals at month 7, 10, 13, and 16.
| Arm | Type | Receives |
|---|---|---|
| Thulium laser (1927nm) and post-treatment topically administered platelet rich plasma (PRP) | Experimental | Device: Fractionated Thulium laser, Procedure: Autologous Platelet Rich Plasma Topical ApplicationAll participating subjects will serve as their own baseline control and will receive treatment of their androgenetic alopecia with LaseMD, a 1927nm Fractionated Thulium laser and post-treatment topically applied autologous platelet rich plasma at monthly intervals for a total of 4 treatment. The total duration of laser application, venipuncture, PRP preparation, and topical administration will take approximately 30 minutes. Post-treatment surveillance: The subject will be observed in the clinic under direct supervision of the treating physician for any post-treatment side-effects for up to 15 minutes. |
| Platelet rich plasma injection | Experimental | Procedure: Autologous Platelet Rich Plasma InjectionAll participating subjects will serve as their own baseline control and will receive treatment of their androgenetic alopecia with autologous platelet rich plasma injection at monthly intervals for a total of 4 treatment. The total duration of venipuncture, PRP preparation, and injection will take approximately 15 minutes. Post-treatment surveillance: The subject will be observed in the clinic under direct supervision of the treating physician for any post-treatment side-effects for up to 15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy male, ≥ 18 years of age at time of informed consent, seeking treatment for hair loss.
- Subject must voluntarily sign and date an IRB approved informed consent form
- Subjects with diagnosis of androgenetic alopecia with hair loss recorded over the past 6 months. (Norwood Hamilton Class 3-4 for males)
- Able to read, understand and voluntarily provide written informed consent.
- Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regime during the study.
Key exclusion criteria (11 listed)
- Subjects does not have the capacity to consent to the study
- Subject has other types of alopecia of the scalp (i.g., alopecia areata, scarring alopecia)
- Use of minoxidil or 5-alpha reductase inhibitors (i.e., finasteride, dutasteride) 3 months prior to screening date.
- Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject.
- Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractionated Thulium laserAlso: LaseMD Lutronic LaserFor this study, the investigators will use non-ablative fractional Thulium laser (1927 nm), provided by LaseMD, (Lutronic, Inc, USA). The non-ablative fractionated treatments with minimal downtime provide synergistic benefit of minimizing tissue damage while improving treatment tolerance and efficiency. The laser works by creating micro-channels in the dermis of the pilosebaceous unit, while leaving bridges of untouched tissue for improved permeability, faster healing, and enhanced delivery of topical treatments. The parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by LaseMD. More than one affected area of the scalp may be treated per session. Each laser treatment will take approximately 10 to 15 minutes per subject. Pretreatment preparation will consist of cleaning the affected area of the scalp with antiseptic, either 70% ethanol or 3% hydrogen peroxide. | Device | Thulium laser (1927nm) and post-treatment topically administered platelet rich plasma (PRP) |
| Autologous Platelet Rich Plasma InjectionPlatelet rich plasma (PRP) will be collected from participant in accordance with FDA section 21CFR640.34 regulation on collection and preparation of PRP. The collected blood will be processed according to manufacturer protocol to obtain PRP, which will be injected with a syringe and needle subcutaneously into the participant's scalp. | Procedure or surgery | Platelet rich plasma injection |
| Autologous Platelet Rich Plasma Topical ApplicationPlatelet rich plasma (PRP) will be collected from participant in accordance with FDA section 21CFR640.34 regulation on collection and preparation of PRP. The collected blood will be processed according to manufacturer protocol to obtain PRP, which will be applied topically with a syringe to one or more affected areas on the participant's scalp that were previously treated with thulium laser. | Procedure or surgery | Thulium laser (1927nm) and post-treatment topically administered platelet rich plasma (PRP) |
Primary outcome
Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at month 7 follow-up.
Time frame: 7 months
Clinician Global Aesthetic Improvement Scale (CGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. Greatly decreased (-3) Moderately decreased (-2) Slightly decreased (-1) No change (0) Slightly increased (+1) Moderately increased (+2) Greatly increased (+3) Based on a live assessment of the subject while referring to the subject's pre-treatment scalp photographs, the clinician will make an assessment of post-treatment hair growth.
Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at month 7 follow-up.
Time frame: 7 months
Subject Global Aesthetic Improvement Scale (SGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. Greatly decreased (-3) Moderately decreased (-2) Slightly decreased (-1) No change (0) Slightly increased (+1) Moderately increased (+2) Greatly increased (+3) Subjects will be given a hand mirror for self-assessment of post-treatment hair growth compared to subject's pre-treatment scalp photographs.
2 secondary outcomes
Percentage of subjects with score of 2 or 3 on Patient Satisfaction Questionnaire at month 7 follow-up.
Time frame: 7 months
Reported pain score on Numeric Rating Scale for Pain for first 4 months during treatment
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
Related trials for Androgenetic Alopecia
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Active, not recruitingPhase 3
Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
Androgenetic Alopecia, Female Pattern Baldness
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
RecruitingPhase 1/2
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
RecruitingPhase 2/3
Phase 2/3 Efficacy and Safety of PP405 in Adult Males
Androgenetic Alopecia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kseniya Kobets, MD principal investigator
Montefiore Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Fractionated Thulium laser, Autologous Platelet Rich Plasma Injection and Autologous Platelet Rich Plasma Topical Application in people with Androgenetic Alopecia, run by Montefiore Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at month 7 follow-up. (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.